Brian Pate

About Brian Pate

Brian Pate helps medical device companies achieve efficient and compliant product…

Experience

1. General Manager

   Softwarecpr

   Jan 2017 — Present

   Brian is a Partner and the General Manager at SoftwareCPR® - experts in FDA regulation (and EU certs) and regulatory affairs, and recognized worldwide for software expertise. At SoftwareCPR®, Brian has provided training internally for FDA, and serves as primary faculty for the AAMI/FDA courses on Software Regulation and the Effective Application of Agile Methods course. He also taught the AAMI Design Controls course in 2015. Brian served on the AAMI TIR working groups for TIR 32 (Medical device software risk management) and TIR45 (Guidance on the use of AGILE practices in the development of medical device software). He has a long track record with helping medical device companies achieve lean, efficient, and compliant processes for software development. In addition to Brian\'s consulting and teaching roles, he oversees day to day operations including marketing, sales, and executive management of the company.

Skills

• Mapp Verification & Validation
• Healthcare
• Design Control
• Software Hazard Analysis
• Product Development
• Software Quality Assurance
• Analysis
• Sdlc
• Regulations
• Embedded Software
• C
• Quality System
• Healthcare Information Technology
• Clinical Research
• Six Sigma
• V&V
• Gmp
• Mobile Medical Apps
• Lean Software Development
• Embedded Systems
• Engineering
• Biotechnology
• Software Process Development
• Manufacturing
• Risk Management
• Iso 13485
• Reviews
• Software Design Reviews
• Software Development
• Medical Imaging
• R&D
• Product Launch
• Capa
• Medical Devices
• Validation
• Management
• Safety Risk Management for Medical Devices
• Agile Methodologies in a Regulated Environment
• Iec62304 Assessments
• Testing